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# FDA OKs Glaukos Intraocular Pressure Drug Implant
- URL: https://www.fdaweb.com/fda-oks-glaukos-intraocular-pressure-drug-implant/
- Published: 2023-12-17T12:00:00.000Z
- Updated: 2026-09-14T14:18:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156005

FDA has approved a Glaukos Corp. NDA for iDOSE TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for reducing intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. The product is designed to deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time, the company says.

Approval is based on data from two Phase 3 pivotal trials (GC-010 and GC-012) that showed the drug “successfully achieved” the pre-specified primary efficacy endpoints through three months and demonstrated a favorable tolerability and safety profile through 12 months. “IOP reductions from baseline over the first three months were 6.6-8.4 mmHg in the iDose TR arm, versus 6.5-7.7 mmHg in the timolol control arm (mmHg range represents IOP reduction means across the six U.S. FDA pre-specified timepoints of 8 a.m. and 10 a.m. at Day 10, Week 6 and Month 3),” the company says. “Based on these outcomes, the FDA concluded in the prescribing information that iDose TR demonstrated non-inferiority to timolol ophthalmic solution in IOP reduction during the first three months. The FDA also noted that subsequently iDose TR did not demonstrate non-inferiority over the next nine months.”

On the safety side, the company says that the most common ocular adverse reactions reported in 2% to 6% of iDose TR patients were increases in intraocular pressure, iritis, dry eye, and visual field defects, most of which were “mild and transient in nature.”